Diagnostic Imaging Techniques for Shoulder Osteoarthritis

(UESOA Trial)

Recruiting at 1 trial location

Overseen By Katie McIlquham

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Age >60, Shoulder trauma, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Osteoarthritis (OA) is a progressive disease resulting from the degradation of synovial joint articular cartilage over time. The hallmark symptom is diffuse aching and progressive pain made worse with activity. Loss of range of motion and compromised function inevitably follow. This degenerative disease can affect the shoulder joint. When symptoms become refractory to conservative treatment such as anti-inflammatory medication, steroid injections, activity modification or physical therapy; surgery (total or reverse shoulder arthroplasty) may be considered. Idiopathic shoulder OA is typically characterized by posterior subluxation of the humeral head upon the glenoid and posterior bone loss. An imbalance in the application of forces applied to the proximal humerus by the posterior and anterior rotator cuff muscles has been postulated to be the leading cause of idiopathic shoulder OA. However, there is only preliminary evidence to support this theory and the etiology of this pattern of deformity is unknown. The theory the posterior humeral head subluxation is a precursor to OA is only supported by very low-level evidence and no longitudinal studies have been conducted. As a result, the cause and natural history of shoulder OA remains unknown. Research into this area is urgently needed to generate knowledge that will inform future treatments aimed at modifying and slowing the progression of shoulder OA and to reduce the need for shoulder replacement therapy. The aim of this project is to develop an understanding of the pathophysiology of shoulder OA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to use diagnostic imaging techniques like Low-dose CT and T1Rho MRI for shoulder osteoarthritis?

Research shows that low-dose CT scans, including those with metal artifact reduction, are generally safe and have been used in various studies for shoulder imaging. T1Rho MRI has been tested in pilot studies and is considered safe for assessing shoulder joint health. ^{1 2 3 4 5}

How is the imaging treatment for shoulder osteoarthritis different from other treatments?

This treatment uses advanced imaging techniques like 3D MRI and ultra-low-dose CT scans to create detailed models of the shoulder, which can help in diagnosing and planning treatment for osteoarthritis. Unlike traditional methods, these techniques offer a non-invasive way to visualize the joint in three dimensions, potentially improving accuracy in diagnosis and surgical planning. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Low-dose CT, Motion Analysis, T1Rho MRI for shoulder osteoarthritis?

Research shows that low-dose CT scans can effectively provide detailed images for diagnosing shoulder issues and planning surgeries, while MRI techniques like T1Rho can offer valuable insights into cartilage health, which is important for understanding osteoarthritis. ^{2 3 7 8 9}

Who Is on the Research Team?

Peter Lapner, MD

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults under 60 with shoulder osteoarthritis, specifically those showing more than 55% posterior humeral head subluxation on imaging. It's not suitable for individuals over 60, those with labral or rotator cuff issues, pre-existing joint deformities beyond grade I, neurological disorders of the upper limb, history of shoulder instability or trauma including fractures.

Inclusion Criteria

Posterior humeral head subluxation >55% (determined from imaging)

I am younger than 60 years old.

Exclusion Criteria

I am over 60 years old.

I have a joint deformity more severe than mild.

I have a rotator cuff injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including T1Rho MRI, qCT, and functional/motion analysis

1-2 weeks

1 visit (in-person)

Ongoing Assessment

Participants undergo T1Rho MRI, qCT, and motion analysis at year 2 and year 4

5 years

2 visits (in-person) at year 2 and year 4

Finite Element Model Validation

Finite element model validation performed in years 2 and 3

2 years

Follow-up

Participants are monitored for safety and effectiveness after assessments

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Low-dose CT
• Motion Analysis
• T1Rho MRI

Trial Overview The study aims to understand the causes and progression of shoulder osteoarthritis by using low-dose CT scans, T1Rho MRI imaging techniques and motion analysis to observe changes in the joint over time.

How Is the Trial Designed?

Group I: Group 1: Early Degeneration ('Disease') Experimental Treatment 3 Interventions

Those who have posterior subluxation of the humeral head and show early signs of degeneration in their shoulder.

Group II: Group 2: No Degeneration ('Healthy') Active Control 3 Interventions

Those who have posterior subluxation of the humeral head and show no signs of degeneration.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The clinical performance of ultra-low-dose shoulder CT scans: The assessment on image and physical 3D printing models. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Low-dose CT with metal artifact reduction in arthroplasty imaging: a cadaveric and clinical study. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

3D-MR vs. 3D-CT of the shoulder in patients with glenohumeral instability. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of MR-derived simulated CT-like images and simulated radiographs compared to conventional radiography in patients with shoulder pain: a proof-of-concept study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

3D-MRI versus 3D-CT in the evaluation of glenoid deformity in glenohumeral arthritis using Dixon 3D FLASH sequence. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

C-arm flat-panel CT arthrography of the shoulder: Radiation dose considerations and preliminary data on diagnostic performance. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Three-dimensional spin-lock magnetic resonance imaging of the shoulder joint at 3 T: initial experience. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[Direct CT-arthrography versus direct MR-arthrography in chronic shoulder instability: comparison of modalities after the introduction of multidetector-CT technology]. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

3DMR osseous reconstructions of the shoulder using a gradient-echo based two-point Dixon reconstruction: a feasibility study. [2022]